New digital health combo aims to ease chronic back pain without surgery
NCT ID NCT07011537
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a digital health program (Hinge Health) plus a wearable pain relief device (Enso) can help people with chronic low back pain feel better and move more easily. About 196 adults with back pain for at least 3 months will be randomly assigned to either the digital program plus device or standard care. The goal is to see if this approach reduces pain and improves daily function better than usual treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 196 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 or over * United Healthcare (UHC) is primary health plan * Mechanical (myofascial), axial back pain (focused around the spine) * Experiencing pain primarily in the low back area * Radicular component of pain has minimal effect on functionality, medication, quality of life * Experiencing low back pain for at least 3 months * Subject able to understand and provide informed consent * Comfortable and willing to accept random assignment to one of two study conditions (intervention or standard care condition) * Has an email account Exclusion Criteria: * Patients that do not own or have access to a smartphone or tablet * Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability * Primary symptoms due to spinal stenosis as evidenced by pseudoclaudication, leg weakness or numbness * Source of back pain related to an acute nerve impingement * Diagnosis of cancer/malignant tumors in the last 5 years * Source of back pain is an infection * History of spinal fusion surgery * Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, or any other implanted electronic device * Has had myocardial infarction within the past 6 months * Has had a coronary stent in the past 3 months * Has radicular pain symptoms that affect functionality, quality of life or medication intake * Has undergone surgery to solve pain related to the study indication in the past 12 months * Is scheduled for upcoming surgery to solve pain related to the study indication * History of opioid or drug use, or excessive alcohol use (excessive alcohol use defined as greater than 3 drinks a day on average), per investigator discretion * History of rheumatological or other inflammatory conditions such as rheumatoid arthritis, systemic lupus, erythematosus, etc. * Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in investigator's judgment * Pregnant women (as determined by self-report) * Has a heart condition that limits the ability to do mild exercise due to symptoms such as fatigue, palpitations, shortness of breath, or chest pain * Has any health condition that limits the ability to do light-intensity exercise such as slow walking or light household chores * Diagnosed with dementia or a similar memory disorder * Has had a fall in the past three months * Unable to move from sitting to standing without help from another person * Unable to stand without assistance from another person or device * Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes * Inability to complete data collection as required * No secondary/coinsurance or plans to change insurance from UHC in the next 3 months * Patients who were recommended spine surgery from a spine surgeon in the 3 months prior to the index month
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Optum Labs
Eden Prairie, Minnesota, 55344, United States
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Other studies related to the condition(s) this trial covers.
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